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A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients

Primary Purpose

B Cell Precursor Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Blinatumomab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Precursor Acute Lymphoblastic Leukemia focused on measuring R/R B-ALL, Blincyto®, AMG 103, Blinatumomab, Acute lymphoblastic leukemia (ALL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 years or older.
  • Participants with B-precursor ALL with any of the following:

    • Either refractory to primary induction therapy or refractory to at least 1 salvage therapy OR
    • In untreated first, second, third or greater relapse or refractory relapse

      • First Relapse is defined as achievement of first Complete Remission (CR) [CR1] during upfront therapy then relapse during or after continuation therapy
      • Primary Refractory disease is defined as the absence of CR after standard induction therapy
      • Refractory relapse is defined as lack of CR after salvage treatment
      • Second relapse or later relapse is defined as relapse after achieving a second CR (CR2) in first or later salvage
      • Refractory to salvage is defined as no attainment of CR after salvage
  • Relapsed or Refractory at any time after first salvage therapy.
  • Relapse at any time after allogenic hematopoietic stem cell transplant (HSCT).
  • Greater than or equal to 5% blasts in the Bone Marrow.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.
  • Participants with relapse or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria:

  • Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and/or clinical signs of CNS leukemia.
  • History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis.
  • Symptoms and/or signs that indicate an acute or uncontrolled chronic infection, any other disease or condition that could be exacerbated by the treatment or would complicate protocol compliance.
  • History of malignancy (with certain exceptions) other than ALL within 3 years prior to start of protocol-specified therapy.
  • Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy.
  • Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy (with certain exceptions).
  • Immunotherapy within 4 weeks before start of protocol-specified therapy. Prior failed CD19 directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed, if treatment ended more than 4 weeks prior to start of protocol therapy.
  • Currently receiving treatment in, or less than 30 days since ending treatment on another investigational study(ies).
  • Abnormal screening laboratory parameters.
  • Female participant: Expected to breastfeed during treatment and for 96 hours after the last dose of treatment.

The above is a summary, other exclusion criteria details may apply.

Sites / Locations

  • City of Hope National Medical CenterRecruiting
  • New York University Langone HealthRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting
  • Fred Hutchinson Cancer Center
  • University of WashingtonRecruiting
  • Royal Adelaide HospitalRecruiting
  • Monash Medical CentreRecruiting
  • Austin Health, Austin HospitalRecruiting
  • The Alfred HospitalRecruiting
  • Universitaetsklinikum Allgemeines Krankenhaus WienRecruiting
  • University of AlbertaRecruiting
  • Vancouver General Hospital, Gordon and Leslie Diamond Health Care CentreRecruiting
  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude HuriezRecruiting
  • Centre Hospitalier Universitaire de NiceRecruiting
  • Hopital Saint AntoineRecruiting
  • Institut Universitaire du Cancer Toulouse OncopoleRecruiting
  • Charite - Universitaetsmedizin Berlin, Campus Benjamin FranklinRecruiting
  • Universitaetsklinikum KoelnRecruiting
  • Universitaetsklinikum LeipzigRecruiting
  • Universitaetsklinikum Tuebingen
  • Universitatsklinikum UlmRecruiting
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIRecruiting
  • Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola MalpighiRecruiting
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaRecruiting
  • IRCCS Ospedale San RaffaeleRecruiting
  • Azienda Ospedaliera Policlinico Umberto IRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Erasmus Medisch CentrumRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Complejo Asistencial Universitario de Salamanca. Hospital Universitario de SalamancaRecruiting
  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i PujolRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Clinica Universidad de NavarraRecruiting
  • Hospital Universitario 12 de OctubreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)

Dose Expansion Phase: Blinatumomab SC1

Ph-IIC: Clinical PK Evaluation of SC Blinatumomab Formulations

Arm Description

Cohorts of at least 3 participants each will be treated with escalating doses of bilinatumomab to determine the maximum tolerated dose (MTD). The MTD will be defined as the dose for which the estimate of the toxicity rate from an isotonic regression (Yan et al, 2017) is closest to the target toxicity rate. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy will be assessed.

Up to 4 cohorts of participants with R/R B-ALL will be enrolled to the preliminary recommended phase 2 dose (RP2D) and schedule determined from dose escalation phase. Each cohort will aim to further assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy.

1 cohort of participants will be enrolled into the Ph-IIC arm. The clinical PK evaluation cohort (Ph-IIC) will be conducted to compare the PK of SC1 and SC2 formulations at the RP2D determined from the dose expansion phase, in participants with R/R B-ALL.

Outcomes

Primary Outcome Measures

Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs)
Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Dose Escalation Phase: Number of participants who experience one or more serious TEAEs
Dose Escalation Phase: Number of participants who experience one or more treatment-related treatment-emergent adverse events
Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs)
Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission (CR)
Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission with partial hematological recovery (CRh)
Phase 2 Ph-IIC: Maximum concentration (Cmax) of blinatumomab SC1 and SC2
Phase 2 Ph-IIC: Average concentration (Cavg) of blinatumomab SC1 and SC2
Phase 2 Ph-IIC: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2
Phase 2 Ph-IIC: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2

Secondary Outcome Measures

Dose Escalation Phase: Minimum concentration over the dosing interval (Cmin) of blinatumomab
Dose Escalation Phase: Cmax of blinatumomab
Dose Escalation Phase: Tmax of blinatumomab
Dose Escalation Phase: AUC of blinatumomab
Dose Escalation Phase and Phase 2 (Ph-IIC cohort): Number of participants who achieve CR/CRh
Dose Escalation, Dose Expansion, and Ph-IIC: Number of participants with incidence of anti-blinatumomab antibody formation
Dose Expansion Phase: Cmin of blinatumomab
Dose Expansion Phase: Cmax of blinatumomab
Dose Expansion Phase: Tmax of blinatumomab
Dose Expansion Phase: AUC of blinatumomab
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Relapse-Free Survival in participants who achieve CR/CRh within the first 2 cycles(R/R B-ALL)
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Overall survival (OS)
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Duration of complete response
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more TEAEs
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more serious treatment-emergent adverse event
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more treatment-related treatment-emergent adverse events
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more AEs
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Summary scores of quality of life at each assessment as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Change from baseline of quality of life as assessed by the EORTC QLQ-C30

Full Information

First Posted
August 18, 2020
Last Updated
October 11, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04521231
Brief Title
A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients
Official Title
A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
June 1, 2027 (Anticipated)
Study Completion Date
March 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. It will also conduct a clinical PK evaluation of SC1 and SC2 blinatumomab formulations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Precursor Acute Lymphoblastic Leukemia
Keywords
R/R B-ALL, Blincyto®, AMG 103, Blinatumomab, Acute lymphoblastic leukemia (ALL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)
Arm Type
Experimental
Arm Description
Cohorts of at least 3 participants each will be treated with escalating doses of bilinatumomab to determine the maximum tolerated dose (MTD). The MTD will be defined as the dose for which the estimate of the toxicity rate from an isotonic regression (Yan et al, 2017) is closest to the target toxicity rate. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy will be assessed.
Arm Title
Dose Expansion Phase: Blinatumomab SC1
Arm Type
Experimental
Arm Description
Up to 4 cohorts of participants with R/R B-ALL will be enrolled to the preliminary recommended phase 2 dose (RP2D) and schedule determined from dose escalation phase. Each cohort will aim to further assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy.
Arm Title
Ph-IIC: Clinical PK Evaluation of SC Blinatumomab Formulations
Arm Type
Experimental
Arm Description
1 cohort of participants will be enrolled into the Ph-IIC arm. The clinical PK evaluation cohort (Ph-IIC) will be conducted to compare the PK of SC1 and SC2 formulations at the RP2D determined from the dose expansion phase, in participants with R/R B-ALL.
Intervention Type
Drug
Intervention Name(s)
Blinatumomab
Other Intervention Name(s)
AMG 103, Blincyto®
Intervention Description
Blinatumomab will be administered as a subcutaneous (SC) injection.
Primary Outcome Measure Information:
Title
Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs)
Time Frame
Up to 29 days
Title
Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Time Frame
Up to approximately 28 weeks
Title
Dose Escalation Phase: Number of participants who experience one or more serious TEAEs
Time Frame
Up to approximately 28 weeks
Title
Dose Escalation Phase: Number of participants who experience one or more treatment-related treatment-emergent adverse events
Time Frame
Up to approximately 28 weeks
Title
Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs)
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission (CR)
Time Frame
Up to 68 days
Title
Dose Expansion Phase (R/R B-ALL): Number of participants who achieve complete remission with partial hematological recovery (CRh)
Time Frame
Up to 68 days
Title
Phase 2 Ph-IIC: Maximum concentration (Cmax) of blinatumomab SC1 and SC2
Time Frame
Up to approximately 4 weeks
Title
Phase 2 Ph-IIC: Average concentration (Cavg) of blinatumomab SC1 and SC2
Time Frame
Up to approximately 4 weeks
Title
Phase 2 Ph-IIC: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2
Time Frame
Up to approximately 4 weeks
Title
Phase 2 Ph-IIC: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2
Time Frame
Up to approximately 4 weeks
Secondary Outcome Measure Information:
Title
Dose Escalation Phase: Minimum concentration over the dosing interval (Cmin) of blinatumomab
Time Frame
Up to approximately 28 weeks
Title
Dose Escalation Phase: Cmax of blinatumomab
Time Frame
Up to approximately 28 weeks
Title
Dose Escalation Phase: Tmax of blinatumomab
Time Frame
Up to approximately 28 weeks
Title
Dose Escalation Phase: AUC of blinatumomab
Time Frame
Up to approximately 28 weeks
Title
Dose Escalation Phase and Phase 2 (Ph-IIC cohort): Number of participants who achieve CR/CRh
Time Frame
Up to 68 days
Title
Dose Escalation, Dose Expansion, and Ph-IIC: Number of participants with incidence of anti-blinatumomab antibody formation
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase: Cmin of blinatumomab
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase: Cmax of blinatumomab
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase: Tmax of blinatumomab
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase: AUC of blinatumomab
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Relapse-Free Survival in participants who achieve CR/CRh within the first 2 cycles(R/R B-ALL)
Time Frame
Up to 68 days
Title
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Overall survival (OS)
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Duration of complete response
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more TEAEs
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more serious treatment-emergent adverse event
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more treatment-related treatment-emergent adverse events
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Number of participants who experience one or more AEs
Time Frame
Up to approximately 28 weeks
Title
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Summary scores of quality of life at each assessment as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Time Frame
Baseline (Day 1) up to approximately 28 weeks
Title
Dose Expansion Phase and Phase 2 (Ph-IIC cohort): Change from baseline of quality of life as assessed by the EORTC QLQ-C30
Time Frame
Baseline (Day 1) up to approximately 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older. Participants with B-precursor ALL with any of the following: Either refractory to primary induction therapy or refractory to at least 1 salvage therapy OR In untreated first, second, third or greater relapse or refractory relapse First Relapse is defined as achievement of first Complete Remission (CR) [CR1] during upfront therapy then relapse during or after continuation therapy Primary Refractory disease is defined as the absence of CR after standard induction therapy Refractory relapse is defined as lack of CR after salvage treatment Second relapse or later relapse is defined as relapse after achieving a second CR (CR2) in first or later salvage Refractory to salvage is defined as no attainment of CR after salvage Relapsed or Refractory at any time after first salvage therapy. Relapse at any time after allogenic hematopoietic stem cell transplant (HSCT). Greater than or equal to 5% blasts in the Bone Marrow (Exception: Isolated Non-central nervous system (CNS) extramedullary disease [EMD]). Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. Participants with relapse or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible. The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and/or clinical signs of CNS leukemia. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (≥ grade 3) CNS events including immune effector cell-associated neurotoxicity syndrome (ICANS) from prior cluster of differentiation 19 (CD19) chimeric antigen receptor T-cell (CAR T) or other T cell engager therapies. Isolated Extramedullary (EM) Disease Symptoms and/or signs that indicate an acute or uncontrolled chronic infection, any other disease or condition that could be exacerbated by the treatment or would complicate protocol compliance. Testicular leukemia History of malignancy (with certain exceptions) other than ALL within 3 years prior to start of protocol-specified therapy. Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy. Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy (with certain exceptions). Immunotherapy within 4 weeks before start of protocol-specified therapy. Prior failed CD19 directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed, if treatment ended more than 4 weeks prior to start of protocol therapy therapy and no prior CNS complications. Currently receiving treatment in or less than 30 days since ending treatment on another investigational study(ies). Abnormal screening laboratory parameters. Female participant: Expected to breastfeed during treatment and for 96 hours after the last dose of treatment. The above is a summary, other exclusion criteria details may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Individual Site Status
Completed
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health, Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Allgemeines Krankenhaus Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Nice
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Universitaire du Cancer Toulouse Oncopole
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Terminated
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Asistencial Universitario de Salamanca. Hospital Universitario de Salamanca
City
Salamanca
State/Province
Castilla León
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients

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